ISO 13485 Certification Services
An organization that is “ISO 13485 Certified” has established an ISO 13485 Quality Management System and has successfully met all of the ISO 13485 standards. ISO 13485 assesses if your Quality Management System is acceptable and effective, with a focus on medical device safety and efficacy. A few details about ISO 13485 Certification: Although some countries have their own set of rules, ISO 13485 is the most common Quality Management System (QMS) standard for medical devices. The Food and Drug Administration (FDA) regulations for medical devices, for example, will be harmonized with ISO 13485 in the United States. Hence it becomes very important to get the ISO 13485 certification services done by a trustworthy organization. ISO 13485:2016 is the most recent version, which was released in March of 2016. Some features of this version are mentioned below · It makes no difference how big or little your company is: Whether it’s one person or a million, · It is NOT a product standa